Triphasic biomaterial for augmentation of the osteoporotic femoral neck: systematic review

Kheder M, Vandepeer M, Forel D, Tivey D
Record ID 32018001656
Authors' results and conclusions: OSSURE® Local Osteo-Enhancement Procedure (LOEP®) is a minimally invasive surgical procedure. It involves the injection of a calcium-based biomaterial (AGN1) into an area of osteoporotic bone loss, where –according to the manufacturer- it reportedly provides immediate strength. The intended outcome is increased bone strength and preventing fragility fractures. AGN1 LOEP is a once-off minimally invasive surgical treatment that aims to resorb and replace the implant material with new bone. AGN1 LOEP is approved in Europe with the CE mark (in 2017) and in the USA, the Food and Drug Administration (FDA) has granted OSSURE LOEP 2020 a Breakthrough Device Designation for the treatment of stable vertebral compression fractures.
Project Status: Completed
Year Published: 2021
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English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Austria
MeSH Terms
  • Osteoporosis
  • Femur Neck
  • Bone and Bones
  • Femoral Neck Fractures
  • Bone Cements
  • Osteoporosis
  • biomaterial
  • fractures
  • minimally invasive procedure
  • surgery
Organisation Name: Austrian Institute for Health Technology Assessment
Contact Address: Garnisongasse 7/20, A-1090 Vienna, Austria
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Copyright: HTA Austria - AIHTA GmbH
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